Cleared Traditional

ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM

K131366 · Roche Diagnostics Operations, Inc. · Chemistry
Oct 2013
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K131366 is an FDA 510(k) clearance for the ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Roche Diagnostics Operations, Inc. (Indianapolos, US). The FDA issued a Cleared decision on October 11, 2013, 151 days after receiving the submission on May 13, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K131366 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2013
Decision Date October 11, 2013
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LFR — Glucose Dehydrogenase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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